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smdr@medics. Class A medical device database@medics. Please take note of the following on the submission of documents online: Attaching Files. Please refrain from opening multiple internet browser window tabs when accessing MEDICS.
Medical device registration. You will need to register your medical device before supplying it in Singapore. Find out how to complete your product registration here. Registration overview Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device.
Sep 13, 2019 · This article was last reviewed on Friday, September 13, 2019. Find out if your Medicine/Medical Devices/Chinese Proprietary Medicines are registered/listed in Singapore.
Dec 4, 2019 · All medical devices registered with HSA are listed in the Singapore Medical Device Register (SMDR). Access Singapore Medical Device Register. Check with the retailer or dealer. Where Can I Obtain More Information? For more information on the regulation of medical devices in Singapore, you may refer to the HSA Website.
Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website. Which regulatory organizations are considered independent reference agencies by the HSA?
Jan 1, 2022 · Medical Device Registration in Singapore: Regulatory Fee Revision for Health Products (Effective 1 July 2022) The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and efficacy.
Before you can proceed to apply for eGIRO, you need to have access to e-Service, “HSA E-SERVICES: SINGAPORE HEALTH PRODUCT ACCESS AND REGULATION E-SYSTEM (SHARE). Please inform your company’s Corppass Admin to grant you the access via the Corppass portal .
Jul 1, 2022 · Registering Medical Devices in Singapore. Classification and Regulatory Pathways. The Health Sciences Authority (HSA) in Singapore closely follows GHTF guidelines to classify medical devices into Class A, B, C, and D, based on their risk levels, ranging from low to high.
Feb 19, 2024 · The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a revised guidance document dedicated to medical device product registration.
This guidance document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database.
